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A prospective clinical study of monoclonal antibody treatment for refractory thyroid-associated ophthalmopathy

A prospective clinical study of monoclonal antibody treatment for refractory thyroid-associated ophthalmopathy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036239
Enrollment
Unknown
Registered
2020-08-22
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid-Associated Ophthalmopathy

Interventions

treatment group:glucocorticoid and rituximablucocorticoid and rituximab

Sponsors

The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: a. Aged 18-60 years; b. In line with the internationally recognized TAO diagnosis; c. Normal thyroid function within 1 month before entering the group: including those who are taking anti-hyperthyroidism drugs or do not need to take drugs, FT3, FT4 is normal, TSH is normal or low; d. Weight 40-70kg; e. Sign an informed consent.

Exclusion criteria

Exclusion criteria: a) Severe cardiomyopathy, liver and kidney insufficient (myocardial ischemic or myocardial infarction, arrhythmic disorder and cardiomyopathy; ALT or AST >= one and a half times normal valve; b) Gastric ulcers, gastrorrhagia, uncontrolled diabetes, uncontrolled hypertension, tuberculosis, mental illness, glaucome, active hepatitis, other autoimmune diseases; c) glucocorticoid allergy; d) Pregnancy test positive, lactating woman; e) Persons treated with radioactive iodine or vaccinated against hepatitis in the first 3 months; f) Received systemic immunotherapy for TAO in the first month before treatment, including oral or intravenous glucocorticoid, other immunosuppressants or orbital radiotherapy et al.

Design outcomes

Primary

MeasureTime frame
Visual acuity;width of palpebral fissure;the degree of exophthalmus;NOSPECS degree;CAS score;Diplopia and/or squint;

Secondary

MeasureTime frame
Quality of life score;Graves Eye Disease Quality of Life Score;

Countries

China

Contacts

Public ContactLu Yingli

The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

luyingli2008@126.com+86 13636352507

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026